Standardized Patient and In Situ Simulation for IV Infiltration Recognition

NCT07514247 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2026-05-07

No results posted yet for this study

Summary

Peripheral intravenous catheters (PIVCs) are widely used invasive devices in hospital settings and are associated with a broad range of complications, among which infiltration is one of the most common and clinically significant. Infiltration, defined as the leakage of intravenous fluids or medications into surrounding tissues, may result in local tissue damage, pain, infection, delayed treatment, and increased healthcare costs. Despite its high prevalence and impact on patient safety, early recognition and appropriate management of infiltration remain challenging, particularly among nursing students.

Conventional educational approaches that rely predominantly on theoretical instruction may be insufficient to develop the clinical reasoning and decision-making skills required for timely identification and management of such complications. Therefore, there is a growing emphasis on the use of innovative, learner-centered educational strategies that promote active participation and experiential learning.

Simulation-based education, including in situ simulation and standardized patient methodologies, has been shown to provide realistic, safe, and effective learning environments that enhance both technical and non-technical skills. In situ simulation enables training within real clinical settings using existing resources and team structures, while standardized patients facilitate the development of communication, clinical assessment, and decision-making competencies.

This randomized controlled trial aims to evaluate the effectiveness of standardized patient and in situ simulation-based training, compared with traditional teaching methods, in improving nursing students' ability to recognize PIVC-related infiltration and enhance their clinical decision-making skills. Secondary outcomes include learning satisfaction and self-confidence.

By integrating evidence-based simulation approaches into nursing education, this study seeks to strengthen clinical competence and contribute to improved patient safety outcomes.

Conditions

  • Patient Safety
  • Peripheral Intravenous Catheter-Related İnfiltration

Interventions

OTHER

Intervention: Standardized Patient Simulation

Description: Participants receive training through standardized patient-based simulation scenarios specifically designed to represent early and progressive signs of PIVC-related infiltration. Students perform patient assessment, clinical reasoning, and decision-making tasks in a controlled environment. Each session includes structured debriefing using an evidence-based model.

OTHER

Intervention: In Situ Simulation

Description: Participants engage in simulation conducted in real clinical settings using existing hospital equipment and workflows. Scenarios focus on the recognition and management of infiltration within authentic clinical contexts. The intervention emphasizes situational awareness, teamwork, and system-based factors. Structured debriefing is conducted following each session.

Sponsors & Collaborators

  • Selçuk Görücü

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
23 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-25
Primary Completion
2026-05-05
Completion
2026-05-25

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07514247 on ClinicalTrials.gov